CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
SleepWell
1 other identifier
interventional
165
1 country
1
Brief Summary
This study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is compared with a control condition of sleep hygiene education.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedDecember 17, 2018
December 1, 2018
3.3 years
October 28, 2014
December 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Improvement in depression and current severity of depression
Improvement in depression is measured by the Clinical Global Impression-Improvement (CGI-I), and severity is measured by the Clinical Global Impression-Severity (CGI-S).
52 weeks from baseline
Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)
PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE).
52 weeks from baseline
Increase in total sleep time across the study period
Total sleep time is calculated from a sleep diary, which participants complete for 2 weeks following each assessment and during active sleep treatment, and from ActiGraph devices, which measure total sleep time and physical activity 24 hours per day during active sleep treatment and for 2 weeks following each assessment.
52 weeks from baseline
Severity of insomnia based on ISI
Insomnia severity is measured by the Insomnia Severity Index (ISI)
52 weeks from baseline
Secondary Outcomes (1)
Severity of depression based on CDRS-R and PHQ-9
52 weeks from baseline
Study Arms (2)
CBT for Insomnia (CBT-I)
EXPERIMENTALCognitive behavior therapy to improve sleep and depression.
Sleep Hygiene (SH)
PLACEBO COMPARATORAttention control placebo comprising sleep hygiene therapy
Interventions
Cognitive behavior therapy for insomnia (CBT-I) comprising stimulus control, sleep restriction, and sleep-focused cognitive therapy. The CBT-I consists of in-person sessions and homework assignments and includes stimulus control and sleep restriction to regularize the sleep-wake cycle; cognitive therapy to address dysfunctional sleep beliefs and bedtime rumination; motivational interviewing to help youth make important health changes; and parental involvement. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.
Attention placebo control focusing on sleep hygiene, consisting of in-person sessions and homework assignments. The sleep hygiene sessions address sleep-related topics such as limiting pre-sleep caffeine intake, sleep-promoting activities, and the impacts of insufficient sleep. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.
Eligibility Criteria
You may qualify if:
- Age 12 to 19
- Major depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- Recent dispense of SSRI antidepressant
- Subjective complaint of insomnia ≥ one month
- Score of ≥ 9 on Insomnia Severity Index
You may not qualify if:
- Active, progressive physical illness or neurological degenerative disease
- Sleep apnea, restless legs, or limb movements during sleep
- Diagnosis of delayed sleep phase syndrome (DSPS)
- Mental retardation, autism spectrum disorder (ASD), or other significant pervasive developmental disability (PDD)
- Sleep treatments including over-the-counter (OTC) sleep medication or CBT for insomnia
- Medications known to alter sleep
- Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Kaiser Permanente Center for Health Research/Northwest
Portland, Oregon, 97227, United States
Related Publications (1)
Clarke G, Sheppler CR, Firemark AJ, Rawlings AM, Dickerson JF, Leo MC. Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial. Contemp Clin Trials. 2020 Apr;91:105967. doi: 10.1016/j.cct.2020.105967. Epub 2020 Feb 28.
PMID: 32114185DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory N. Clarke, PhD
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2014
First Posted
November 14, 2014
Study Start
March 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
December 17, 2018
Record last verified: 2018-12